BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Federal Trade Commission
Farmers Insurance
Express Scripts
Daiichi Sankyo

Generated: November 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090951

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NDA 090951 describes EPINASTINE HYDROCHLORIDE, which is a drug marketed by Apotex, Sun Pharm Inds, Somerset Theraps Llc, Akorn, Breckenridge Pharm, and Sandoz Inc, and is included in six NDAs. It is available from five suppliers. Additional details are available on the EPINASTINE HYDROCHLORIDE profile page.

The generic ingredient in EPINASTINE HYDROCHLORIDE is epinastine hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the epinastine hydrochloride profile page.

Summary for 090951

Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 090951

Suppliers and Packaging for NDA: 090951

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC 090951 ANDA Somerset Therapeutics, LLC 70069-008 70069-008-10 10 CARTON in 1 CARTON (70069-008-10) > 1 BOTTLE in 1 CARTON (70069-008-01) > 5 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:Oct 31, 2011TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Chinese Patent Office
Farmers Insurance
Federal Trade Commission
Argus Health
Johnson and Johnson
Cantor Fitzgerald

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